NCT06484660|Recruiting
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Sponsor study identifier
interventional
40
1 country
1
Study Start
August 1, 2021
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery. The main question it aims to answer is: \- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery? Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time. Quality of life and global morbidity will also be analyzed. Participants will:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2021
Actual (reported)June 26, 2024
Actual (reported)July 3, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Healing rate
Healing will be measured if 4 criteria are present: no supuration or pain for more than a week, no open external fistulous orifice, no palpable trajectory, no internal fistulous orifice and no tract or collections in 3D endoanal ultrasound.
six months
Postoperative pain
one week
Global morbidity
one month
Quality of life score
six months
Fecal incontinence
six months
Surgical treatment of complex perianal fistula. Less tissue damage. Electrocoagulation source with 75% lower power. Better de-epithelialization of the intra-sphinteric tract. More precise closure of orifice. More consistent mucosal flap
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Fernandez-Hurtado I, Pages-Valle N, Castro-Suarez M, Sarubbo MF, Baena-Bradaschia S, Cifuentes-Rodenas JA, Serra-Aracil X. Microsurgery in mucosal advancement flap repair: a microscope-assisted, tissue-sparing approach for managing complex perianal fistulas within the IDEAL Stage 1 framework. Surg Endosc. 2026 Jun;40(6):5387-5396. doi: 10.1007/s00464-026-12876-5. Epub 2026 May 18.
First Submitted
June 26, 2024
First Posted
July 3, 2024
Study Start
August 1, 2021
Actual (reported)Primary Completion
December 31, 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 7, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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